BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX MONORAIL

    MDR report key: 2183057 · Received July 28, 2011

    Report

    Report Number
    2134265-2011-03064
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 5, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR# 2134265-2011-03075. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE A BALLOON RUPTURE OCCURRED. THE 99% STENOSED, 3.0X8MM DE NOVO TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED 2ND OBTUSE MARGINAL (OM2). THE PHYSICIAN ATTEMPTED TO DIRECT STENT THE LESION WITH A 3.00X12MM ION STENT; HOWEVER, THE DEVICE WAS UNABLE TO CROSS THE LESION AND UPON WITHDRAWAL OF THE DEVICE, THE STENT BECAME DISLODGED IN THE SECOND OM2. A 2.00X15MM APEX BALLOON CATHETER WAS ADVANCED TO THE LESION IN AN ATTEMPT TO RETRIEVE THE DISLODGED STENT. THE BALLOON WAS INFLATED TO 6ATMS AND THE PHYSICIAN ATTEMPTED TO DRAG THE DEVICE BACK ALONG WITH THE STENT; HOWEVER, THIS ATTEMPT ONLY CAUSED THE STENT STRUTS TO FLARE. THE BALLOON CATHETER WAS RE-ADVANCED AND IN AN ATTEMPT TO CRUSH THE STENT AGAINST THE VESSEL WALL, THE BALLOON WAS INFLATED SEVERAL TIMES AND UPON THE 5TH INFLATION TO 14ATMS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED FROM THE PATIENT AND THEN MULTIPLE SUCCESSIVE BALLOONS WERE USED TO CRUSH THE STENT AGAINST THE VESSEL WALL, STARTING WITH A 1.25MM NON BSC BALLOON, FOLLOWED BY FOUR BSC BALLOONS, SIZES 1.5MM, 2.0MM, 2.50MM AND 3.0MM. IT WAS NOTED THAT THE PATIENT EXPERIENCED CHEST PAIN DURING THE ATTEMPT TO CRUSH THE STENT. THE PROCEDURE WAS COMPLETED AT THIS POINT WITH NO ADDITIONAL PATIENT COMPLICATIONS REPORTED AND MINIMAL CHEST PAIN. THE PATIENT'S CURRENT CONDITION IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX MONORAIL CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493895915200 14350068

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR EBU, AL1, MACH 1 GUIDE CATHETERS| ALL STAR, PILOT GUIDE WIRES